Neoprobe GDS Control Unit — Class III medical device recall Z-0070-2021
Terminated recall by Devicor Medical Products Inc, reported 2020-10-14. It was discovered during a documentation review that China has the software version as v5.01 approved for use
| Recall number | Z-0070-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Devicor Medical Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2020-09-07 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2023-05-09 |
| Countries outside the US | CN |
| Quantity | 49 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00841911100317 |
| Serial numbers | 122066557, 122066558, 122066559, 122066560, 122066561, 122666652, 123066667, 123066668, 123066669, 123266693, 123266694, 123366695, 123366696, 123366697, 123366698, 123366699, 123366700, 123366701, 123366702, 134467282, 143367591, 144867780, 145067796, 150367828, 150367829 and 24 more |
| Model numbers | NPCU3 |
Product
Neoprobe GDS Control Unit, Model Number NPCU3
Reason for recall
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0070-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.